Coronavirus Vaccine

Lord Patel Excerpts

Thursday 3rd December 2020 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, as we embark on a mass vaccination programme, it is important that we follow up all those who are vaccinated, or at least a cohort of them, with whatever vaccines are used, in a scientific way. It is important that structured scientific data collection is implemented. Do the Government plan to do that, and who will be doing it? I hope that it will be UK academic institutions, because there is much more science to learn post vaccination about the effectiveness of different vaccines and the science of the new way of developing these vaccines.

[Lord Bethell (Con)]

As ever, the noble Lord is extremely wise in his observation. He is entirely right to hold us to account. There is no point in enjoying this fine moment too much when you have the noble Lord, Lord Patel, on your case reminding you about the next big challenge around the corner. He is right that pharmacovigilance is essential. We need to make sure that this and other vaccines work and that we learn from the behaviours of all of them. That is precisely why we put the deployment of this vaccine through the NHS. There was a temptation to set up an alternative agency and focus on the actual injection of the vaccine over all other matters. Instead we have run it through the NHS digital process, which means that all the information around the vaccine is put very firmly into the GP record. That means that we can do population-wide analysis of the results of the vaccine. We have a very large research community in the UK both in the companies such as Pfizer, which, as he knows, are responsible for pharmacovigilance, and in the university sector. We will have all those records available for them to do the follow-up work that he rightly emphasises.

Covid-19: Vaccines and Medical Equipment

Lord Patel Excerpts

Wednesday 25th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, we have extremely detailed and energetic plans to deal with misinformation, which is based on confusion, and disinformation, which is based on malice. It would not be right for me to go through those plans in detail at the Dispatch Box, but I reassure my noble friend that they are in place and are being characterised by a degree of consideration for those who have concerns about the vaccine. It is a grave undertaking to have an injection such as that. People naturally have searching questions they would like to ask, and we are trying to meet those questions with a degree of thoughtfulness and to answer them in the spirit in which they are asked.

[Lord Patel (CB) [V]]

My Lords, my question follows on well from the previous one. The development of highly effective vaccines against Covid-19 is a remarkable scientific advance. It is crucial that the public have absolute confidence and trust in their use, which they should. This will be reinforced when the scientifically-led process of market approval by the regulator and scrutiny by the wider science community is completed, following publication of the peer-reviewed data. Can the Minister assure the House that there will be no political interference in any way to speed up that process before the vaccines are made available to the wider public?

[Lord Bethell (Con)]

I thank the noble Lord for the opportunity to make this crystal clear: the MHRA is an independent regulator, its work on vaccine approval has no political interference whatever and there is no pressure on either time or outcome. I pay tribute to those at the MHRA, who are extremely dedicated to the cause. We are going to approach the entire process with a spirit of transparency for exactly the reasons the noble Lord identified. Public trust is essential, and the only way we can gain the public’s trust is by being open and honest about how we go about these approvals. That is the way we will pursue the process.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I now call the noble Baroness, Lady Wheeler. No? I gather that the noble Lord, Lord Patel, wants to speak. I call Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I sent in a request to speak after the Minister. I am grateful to her for her lengthy response, but in a way it just shows that there will be considerable areas of divergence once we exit Europe, even after we exit Europe and the agreement with the EU has expired. What the Minister said is correct—that maybe the emergency power regulations will allow us to ask questions—but those are only emergency powers, and this is longer-term.

My amendment asks for an indication, on at least a yearly basis, of where divergences are occurring. It is interesting that the Minister said that the statutory instrument is now available and will be debated in due course. Of course it is available now—although I do not know when it was made available—and we will have an opportunity to debate it. However, the MHRA was already giving guidance on the basis of that instrument before we had seen it or debated it. The Minister’s reply did not therefore satisfy the intention behind my amendment—although I will, of course, not move it today—in terms of the necessity for the Government to produce a report of where divergences are occurring and why.

[Baroness Penn (Con)]

To address the noble Lord’s question about when the statutory instrument was laid, I believe it was on 20 October. I think the statutory instrument laid on 20 October, which we shall debate, is not the Government’s approach to an answer on how we deal with the future issues of regulating medicines, medical devices and vet meds in Northern Ireland and Great Britain. What I was trying to express to the noble Lord is that we have a mechanism that means the Minister will report to Parliament every two years, both looking forward to prospective changes and back at any changes that may have been made. Of course, where new regulations are proposed there will be public consultation on those, but there will also be reports to Parliament ahead of that about the intentions, and those reports will provide a mechanism, which I think the noble Lord wants, to ensure that these issues are discussed properly in Parliament in future.

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[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I hesitate to disagree with my noble friend, but I think it is on page 34—but then, of course, I might have an old edition of the Bill as well, just to confuse things.

The reason for supporting this is the unease about provisions in Clause 27 and Schedule 1. The Delegated Powers Committee concluded that

“in the absence of a full justification … allowing the ingredients of criminal offences … and … the penalties for existing offences to be set by delegated legislation”

amounts to “inappropriate delegations of power”. The Constitution Committee said:

“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


The Minister has made certain modifications, but I think the general principle still holds good.

The guidance to be issued under paragraph 13 of the schedule is likely to be extensive, including: the imposition of a monetary penalty; the notices to the person it is proposed to fine and the grounds for so doing; the representations that have been made; the appeals process; and the consequences of non-payment. As my noble friend said, lines 9 and 10 on page 34 provides that

“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph”.


Given that the Secretary of State is the person publishing the guidance, it is puzzling that he or she is required only to “have regard to” the very guidance that he or she has published—hence my noble friend’s amendment to require the Secretary of State to “act in accordance with” the guidance. I look forward to hearing from the Minister as to why the Bill is drafted to give the Secretary of State wider discretion on that.

[Lord Patel (CB) [V]]

My Lords, I speak very briefly to support this amendment. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath, have covered the argument extremely well. As the noble Lord said just now, the guidance is produced by the Secretary of State but, when you look at it in practice, it says that the Secretary of State “must have regard to” the guidance—that is, can take note of it but does not have to follow it.

I am a doctor and am used to following guidelines. If I do not follow the guidelines, I am liable to be reported; if I do not follow them for any reason in the management of a patient, I am expected to write down as to why I did not follow them. I am not expected to take note of it or have regard to it—I am expected to follow it. The amendment proposed by the noble Baroness, Lady Thornton, addresses exactly that point: why is the Secretary of State not asked to follow the guidelines which he or she drafted?

[Lord Sharkey (LD) [V]]

We all know that the words “have regard to” create no real obligations, whereas the words “act in accordance with” do create real obligations. Clause 13 seems to contain important restrictions on the actions of the Secretary of State, but it does so via guidance. As the Bill stands, with its “have regard to” wording, that guidance has no statutory force. If the restrictions are to have any reality—and I assume that the Government would like them to, or they would not have written them into the Bill—we must replace “have regard to” with “act in accordance with” as the amendment proposes. We support the amendment.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

Finally, the Minister’s letter of 9 November updates on the ongoing process of consultation on Clause 16 with the devolved authorities. The Scottish Health and Sport Committee has agreed to recommend consent to the clause to the Scottish Parliament and Northern Ireland officials have laid a legislative consent memorandum at the Assembly business office for scrutiny. However, in Wales there are “residual concerns”. Can the Minister tell us what these are and what has been done to address them? As a result of the overall consultation, does the Minister envisage changes to the Bill on Report and, if so, will he undertake to ensure that any such amendments are circulated to Peers in advance of their submission to the Marshalled List? I beg to move.

[Lord Patel (CB) [V]]

My Lords, in speaking to my Amendment 127, I also speak in support of the amendments referred to by the noble Baroness, Lady Wheeler, on consultation with the devolved Administrations. While Scotland is devolved in terms of healthcare, the regulations on medicines and medical devices, particularly market authorisation, is not. I support the comments on consulting the devolved Administrations and I have no doubt that the Minister will respond.

I am extremely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for adding his name to my Amendment 127. I am pleased to see that he might speak to it later. The amendment would add to line 9, page 24 of the Bill, the words

“patients and end users directly affected by the regulations”.

It would strengthen the consultation provision by requiring that patients and end users be part of any consultation relating to potential new regulation on medicines, veterinary medicines and medical devices.

Clause 41 creates a duty to consult the relevant authorities when using the delegated powers to make provisions for medicines, veterinary medicines and medical devices. However, this duty refers only to who the authority thinks it should consult, giving a wide area of discretion and providing no guidance or guarantee on consulting patients and end users of medicines and medical devices.

The Cumberlege review found widespread failure to listen to patients’ voices. It recommended that the regulatory framework underpinning the MHRA, and medicines and medical devices in general, be reformed to better take into account patients’ perspectives in the future. In addition, the review recommended that the MHRA regulatory framework should have a requirement to demonstrate how patient views have been taken into account and influenced regulatory design. With this in mind, it is surely crucial that any duty to consult on the exercise of powers should also include reference to the need to consult patients and end users of medicines and medical devices where that is considered reasonable.

I have been deliberately brief because this proposal is so obvious that I do not, I hope, need to speak at length. I am sure that the Minister recognises this, and I look forward to his response.

[Lord Sharkey (LD) [V]]

My Lords, all the amendments in this group deal with the very important question of consultation. As the DPRRC has pointed out in its report on the Bill, consultations are not a substitute for proper parliamentary scrutiny, which the Bill so obviously fails to provide, but in the absence of any real parliamentary mechanisms for real scrutiny, consultations take on an added importance.

Clause 41 is slightly improved by the Government’s Amendment 126. The obligation to consult the devolved Administrations is obviously critical, although it would be helpful if the Minister could explain why in Northern Ireland it is the Department of Health that must be consulted rather than Ministers.

The Minister may also be able to reassure the Committee that the government amendment does not provide only one overriding consultation; the text seems to suggest that when it refers to carrying out “a public consultation”. Can we assume that there will be not portmanteau consultations but individual consultations on each proposed significant policy introduction, change or amendment?

The introduction of a new obligation in proposed new subsection (1B) to include a summary in the consultation document, with the relevant authority’s assessment of the matters addressed by the proposed regulations is welcome, as far as it goes. But quite what depth or rigour should these assessments have? Can the Minister assure the Committee that the assessments will have the same reach, depth and rigour as the standard impact assessments produced for SIs?

Apart from naming the devolved Administrations, it is notable that the government amendment does not specify, or even hint at, who should be consulted in any of these consultations. The Bill is entirely silent on the matter. This leaves open the possibility of narrowly drawn consultations and the omission of important interested groups, not to mention short consultations over holiday or very busy periods. I am particularly concerned that the voice of the medical research charities be clearly heard in all the appropriate consultations. I remind the Committee of my interests as chair of the Association of Medical Research Charities, whose 150 members spent £1.9 billion on research last year—the same amount as was spent by the Government. Despite this enormous contribution, the Government have form in overlooking the medical research charities sector. It took an amendment moved in your Lordships’ House to persuade the Government to agree that the board of UKRI should include a person with experience of the sector. We do not want to see the same omission here.

Our Amendment 129 is very similar to Amendment 128 in the name of the noble Baroness, Lady Thornton, which we are happy to support. Both amendments list who must be included in any consultation. The lists should not be contentious or surprising. We include

“representatives of the relevant patient groups … medical research charities”

and pharma as statutory consultees, along with academic researchers. We leave it open to the relevant authorities to add others to that list.

Our amendment also addresses the problems that could be caused by short and short-notice consultations, perhaps over holiday periods among a less than comprehensive range of consultees. It simply requires the relevant authorities to publish on their websites the terms, start dates and lengths of the consultations, along with the proposed consultees and

“date and method of the publication of … results”.

I rather hope that the Minister will tell us that this part of our amendment is not necessary. I hope that he will see our amendment as an opportunity to give firm assurances to the Committee that the groups we name will be consultees, and about the form and detail of each consultation, as we propose. I hope the Minister will feel able to oblige us.

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Moved by

[Lord Patel]

108: Clause 35, page 19, line 22, at end insert—
“( ) The Secretary of State must disclose information for the purpose of warning the public about concerns relating to a medical device where there is a clear threat to public safety.”Member’s explanatory statement
This amendment places a duty on the Secretary of State to disclose the information where there is a clear threat to public safety.

[Lord Patel (CB) [V]]

My Lords, in moving Amendment 108, I will also speak to Amendment 114. I am immensely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for his support. I beg noble Lords’ indulgence because I intend to explore these two amendments in some depth as I have some concerns about them.

Amendment 108 places a duty on the Secretary of State to disclose information

“where there is a clear threat to public safety.”

Clause 35 provides that the Secretary of State

“may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.”

This is welcome, but the power is discretionary. There is no duty to disclose information in these circumstances. It is not clear why there should not be an unambiguous duty to disclose information to the public where their safety is an issue. The Government have repeatedly committed themselves in their guidance and policy documents to patient safety as their primary concern, and have given reassurances about it in the other place. However, this clause is yet another example of where there is no explicit legal commitment to patient safety. For this reason, an amendment to this clause is suggested to create a duty to disclose information where there is a threat to medical device safety.

In addition, it must be queried what is meant by a “threat to public safety” and how any such threat is to be judged or even detected. The Cumberlege review reviewed the failure of medical professionals and the system in general to listen to patients’ own reports of pain and the seriously adverse effects of their implants. The duty to disclose a threat is only as meaningful and effective as the processes behind it that monitor and capture the information relating to patients’ adverse events. A safety issue will not be recognised if patients are not being taken seriously.

Part of the findings of the Cumberlege review related to the ineffectiveness of the current yellow card system for self-reporting adverse events. There is a lack of a clear and well-publicised route for patients to report their experiences. Clear and effective processes need to be in place to capture the information relevant to identifying potential threats to public safety. This duty to disclose should be supported by such processes.

Clause 16 gives the power to create an information system, and a later amendment introduced by the noble Baroness, Lady Cumberlege, on the setting up of a patient safety commissioner, could form part of the processes needed to ensure that the experiences of patients and the reporting of adverse events are effectively monitored, recorded and evaluated. However, effective self-reporting processes and clear routes for patients to self-report need to be established. Clarification of how such reporting is to be integrated into effective communication across the NHS and the medicines and medical device regulatory framework as a whole is needed.

As the Bill stands, so much is left unsaid and what has been laid out for Parliament to discuss was drafted and conceived before the findings of the Cumberlege review were published. Any patient safety commissioner would need to be properly resourced if they were to work in practice—equally there should be more consideration by the Government of processes for patient reporting and communication across the system. That ought to be put before Parliament.

Amendment 114 would mean that Regulation 3B on the requirement for confidentiality in the Medical Devices Regulations 2002 would remain in place. It is suggested in the Bill that this is removed. Clause 37 provides for “Consequential and supplementary provision”. Subsections (3) to (7) of Clause 37 variously amend the Medical Devices Regulations 2002. In particular, subsection (5) removes Regulation 3B from the 2002 regulations. This was only recently inserted into the law by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. Regulation 3B requires that

“all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect … (a) personal data in accordance with the Data Protection Act 2018; (b) commercially confidential information … (c) the effective operation of … inspections, investigations or audits.”

It is not clear why the requirement for confidentiality has been removed so soon after it was created. While Clause 35 provides that commercially sensitive data cannot be disclosed except where necessary for the Secretary of State to warn of serious harm in civil proceedings or criminal proceedings, no other clauses in the Bill reflect the similar requirements that have now been removed by Clause 37. It is concerning that in removing the requirement for confidentiality, the Bill seems to emphasise protection for commercial interests more than those of patients and users.

The Government should provide clarity on why they wish to remove this condition to respect patient confidentiality in operating the Medical Device Regulations. This not notwithstanding, Clause 37(5) should be removed.

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[Lord Patel (CB) [V]]

My Lords, before I start, let me thank my noble friend Lady Cumberlege enormously for putting her name to Amendment 108. I apologise for not alluding to that earlier.

The noble Lord, Lord O’Shaughnessy, got it: my amendment leaves it to the discretion of the Secretary of State that there might be times when disclosure is not required.

To my friend the Minister, I say: good try, but I am not convinced. I do not see why my amendment cannot be accepted—it provides discretion but just removes “may”.

As far as Amendment 114 is concerned, the point is exactly this. The Minister may recollect the journalist’s report on the regulation of devices in the EU, which raised concerns about manufacturers not agreeing to provide safety information that they may have had when they were testing the devices. Removing that requirement for manufacturers does not help patient safety—hence my amendment asking to leave Regulation 3B as it is.

I have listened. In the meantime, I beg leave to withdraw the amendment.

Amendment 108 withdrawn.

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[Lord Patel (CB) [V]]

My Lords, first, it was a privilege to put my name to the amendment moved by my noble friend Lady Cumberlege. It is a pleasure to follow her powerful speech, which made the case for an independent patient safety commissioner so powerfully that I am tempted to say that no more needs to be said about the amendment except for the Minister to accept it. But of course I cannot do that. I will try to make a case for why now is the time to accept what the noble Baroness is asking for. The time for her amendment has come.

I strongly support the amendment. It was one of the key recommendations of the noble Baroness’s report First Do No Harm to establish an independent commissioner for patient safety and to do this through legislation. The need to address patient safety as an important aspect of healthcare was identified in England following the publication of the report An Organisation with a Memory. This was the watershed moment in the history of patient safety development. In 2001, a report was produced, Building a Safer NHS for Patients, which led to the establishment of the National Patient Safety Agency for England; a national reporting and learning system was to be developed as part of it. In 2006, Safety First, a report for patients, clinicians and healthcare managers, was published, with the objective of recasting the functions of the National Patient Safety Agency. It was after that that I took the chair of it.

The National Patient Safety Agency did develop several good and respected methodologies and publications, and introduced some fundamental patient safety protocols, but it lacked the power and authority of an organisation established in statute. Functioning as an arm’s-length body of the Department of Health, and at its behest, was not the way to establish patient safety. In my view, it weakened its ability to deliver patient safety across the NHS.

As chair, I remember having to try to persuade management at NHS Confederation meetings that alert notices related to patient safety needed to be implemented. This lack of statutory authority meant that hospital trusts were not required to follow any guidance or alert notices. On Friday 1 June 2012, the functions of the NPSA were transferred to the special commissioning board as the NPSA fell victim to the cull of quangos. So what has happened since? Regulatory organisations have come and gone. NHS structures have changed and continue to do so. The NHS is a bit of a political football; I remember that, when I suggested that the political parties stop using it as one, the noble Lord, Lord Hunt, laughed at my comment. Change is a constant feature.

Patient safety documents and policies from 2000 to the present day all sound alarmingly familiar: progress is slow and incremental, even at present. An NAO report criticised the pace of change as regards patient safety, saying that it was too slow and that those who manage trusts focused more on financial budgets than patient safety. One result was the Mid Staffs crisis: we all remember how devastating that report was, particularly in what it had to say about the major patient safety failings.

We now have another devastating report, First Do No Harm. It is the second, and I hope the last, call for us to establish patient safety through legislation and on behalf of patients. The Government’s response to the Francis report defines the current patient safety system. Patient safety became an important aspect of government policy, with several initiatives and three global ministerial meetings, et cetera, but the processes are the same. Have things changed? In my view, not much, especially in terms of a clear demonstration of reducing patient harm. The patient safety organisations that exist are still part of and accountable to NHS departments, not to patients.

The noble Baroness focused her amendment on the safety of medicines and medical devices. Of the top five areas of patient safety errors, harm related to medicines and medical devices rank second and fourth. She is right to focus on these two areas as the first task of the commissioner for patient safety. A 2018 review of errors related to medicine estimated that 237 million errors occur every year in England. The national reporting and learning system had 204,000 incident reports related to medicine, while 712 deaths are attributed yearly to medicine-related harm, costing annually something like £70 million.

Data in relation to the harm associated with medical devices is not as readily available, except when investigated as part of a report such as First Do No Harm. However, figures from the USA can be used as a proxy, as its larger population may give some indication of the scale and types of devices implicated. A recent report in the USA showed the following as examples: 60,000 cases related to the use of surgical mesh; a similar number in relation to defibrillators; and 104,000 cases related to hip prosthesis. There were many more. These data clearly show not just the level of safety issues in relation to medicines and medical devices but the need to address them.

It is time to give patient safety the legal status it needs, as the noble Baroness, Lady Cumberlege, said. It is time for a bolder and more ambitious vision to make patient care safer. I believe that her amendment does this and I strongly support it.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that there may be a delay in the vote taking place in the House for technical reasons. I do not think that we can go on here indefinitely so I suggest that I call the noble Lords, Lord Hunt of Kings Heath, and we break then regardless.

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There is deep concern about this issue and what happens if Northern Ireland and Great Britain end up with increasingly different legislation covering medicines and medical devices. I look forward to the debate and the Minister’s response.

[Lord Patel (CB) [V]]

My Lords, I will speak to Amendment 120 and, again, I am very grateful to my friend the noble and learned Lord, Lord Mackay of Clashfern, for joining me on this amendment. I beg noble Lords’ indulgence because, when I read the legislation and the Bill related to this and then looked at the advice or guidance issued by MHRA, I got more and more confused about what the divergence is going to be, how much of it there will be and how clear the Bill is. I am sorry, but I will be labouring the point at length to get some answers.

My proposed new clause would require the Secretary of State to report on

“regulatory divergence between Northern Ireland and the rest of the United Kingdom”.

This amendment would address the issues of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom. In relation to medicines and veterinary medicines, Northern Ireland is referred to separately from the rest of the UK. This means that, as set out in Clause 1(4)(b) and Clause 8(4)(b), the power to make regulations in respect of Northern Ireland lies with the Department of Health in Northern Ireland or both the department and the Secretary of State, when acting together.

Clause 40 limits the capacity of the Department of Health in Northern Ireland to act alone, only allowing it to do so when it would be

“within the legislative competence of the Assembly, and … would not require the consent of the Secretary of State.”

It is not clear in the Bill which areas would be in the sole competence of the Northern Ireland Assembly. Will the Minister clarify that?

Furthermore, while powers on medical devices are not reserved, the guidance most recently published by the MHRA paints a picture of two different systems—market authorisation and registration, among other issues—and distinguishes between the “Northern Ireland market” and the “Great Britain market”. This implies that regulation different from that in the rest of the UK may be intended for Northern Ireland in respect of medical devices.

The MHRA published guidance on medicines and medical devices based upon the potential situation at the end of the transition period, days before this House was due to sit for the Second Reading of the Bill. This advice implies that a dual system would be operating in respect of Northern Ireland for both medicines and medical devices due to the operation of the Northern Ireland protocol, to which the noble Baroness, Lady Wheeler, referred. This assumes that the Government will actually honour that agreement. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland.

The MHRA guidance makes a distinction between the EU market, the market of Great Britain and the market of Northern Ireland. It sets out that CE marks will cease to be recognised in the market of Great Britain from July 2023, unless the products in question are from manufacturers based in Northern Ireland. There are essentially two different baskets envisaged in the guidance for manufacturers that are based in Northern Ireland to bring a medicinal or medical product to the markets of Great Britain and Northern Ireland.

The first is to go through UK-based approved bodies for their assessments and market authorisations, which would be approval for the Great Britain or Great Britain and Northern Ireland markets, but it would not be recognised in the EU. The second is to submit their application to approval or notified bodies in the EEA, gaining a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market. Noble Lords will see how confusing the whole system sounds.

In contrast, manufacturers based in Great Britain would need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland but would need to undertake the separate task of getting an EU-based responsible person and applying separately for a CE mark in the EU if they were to bring their product to the EU market.

Further, from 30 June 2023, CE-marked devices originating from the EU market but not manufactured in Northern Ireland will no longer be able to flow to Great Britain. This regulatory set-up in Northern Ireland could therefore be an incentive for EU manufacturers to base their European operations in Northern Ireland to have unfettered access to both markets. Discussions about whether this constitutes state aid and would distort the EU single market are still ongoing.

On the face of the MHRA guidance, it appears that the recognition of the CE mark on medicines and devices coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. It certainly suggests a dual system applying between Northern Ireland and the UK, but the extent to which those systems will diverge in substance in future is not clear. It is not clear how systems of pharmacovigilance or the monitoring of medical devices will be co-ordinated for products available in the Great Britain market that are manufactured in Northern Ireland and subject to EU regulations and monitoring. If monitoring systems and databases are to be fit for purpose in the EU, surely it is essential that the UK has access to EU databases. In the absence of this access, how can the Government guarantee, or claim to be prioritising, the safety of patients?

What is clear, because the guidance states it, is that draft regulations with reference to medicines and medical devices exist but have not yet been introduced to Parliament. These draft regulations are what the guidance claims to be based on. If these regulations exist to the extent that the MHRA is publishing guidance based on them on issues of significant policy in these areas, why has this House not had sight of them? Why have they not been included as part of the substance of the Bill where they would receive proper scrutiny and provide much-needed clarity to all stakeholders for medicines and medical devices?

The situation regarding regulatory alignment or divergence between Northern Ireland and the rest of the UK is politically charged and should be dealt with explicitly. Given the potential for some aspects of medicine and veterinary medicine to be subject to the distinct competence of the Northern Ireland Assembly, there is potential for the requirement to have regard to “attractiveness” to have different interpretations in Northern Ireland and the rest of the UK. Further, the ambiguity surrounding the Northern Ireland protocol and its implications raises the potential for divergence, even where the United Kingdom Government have competence to regulate in respect of medical devices. For these reasons—I hope that I have made this point at length—the Government should clarify the position. This amendment would provide greater transparency about the potential regulatory divergence with a commitment to mitigate where possible.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.

During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.

In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?

I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.

There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.

There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.

Covid-19 Update

Lord Patel Excerpts

Thursday 12th November 2020 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, the Minister referred to several areas where the lateral flow test will be deployed. The early reports from Liverpool’s mass screening using the test suggests that it performs well, with higher specificity and sensitivity, meaning that there is a negligible number of false positives and false negatives. That being so—and accepting that the vaccine will change the whole scene when it is available—apart from the areas that he has already mentioned, can he confirm what I have just said and give us the latest figures from Liverpool? Can he go on to say what plans the Government are making for the deployment of this test in other public areas to open up the economy?

[Lord Bethell (Con)]

I thank the noble Lord for his characteristically detailed and forensic question. The lateral flow test, as I am sure he knows, has the terrific advantage of giving very few false positives, but we do not pretend that it gives a clinical-level analysis of all the negatives. We therefore do not use it in a clinical setting as a symptomatic test; we use it as a screening test for asymptomatic cases. That is why it has been so valuable in a mass testing environment such as Liverpool. We can back up the tests of those who are positive with a double test, either with another lateral flow test or with a PCR test, to ensure that we do not create a problem with too many false positives. We are working on the protocols now to figure out exactly what kind of rate of second testing we need to get a fair analysis.

The noble Lord is entirely right that the vaccine will be a game-changer, but not everyone will take it immediately and we are not sure how long each vaccine will last for, so there will be a role for testing even after the vaccine has been deployed. In the meantime, testing is very much focused on social care, clinical workers, schools and universities. Those are the four areas where we are focused at the moment, but we hope it can be used further to enable the opening of the economy, as he alluded to.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Jolly (LD)]

My Lords, this Bill is about medicines and medical devices, and also includes veterinary medicines, which I understand the profession welcomes. I support government Amendment 131.

I confess, I wondered whether the veterinary part of the Bill was a bit of an afterthought, as although veterinary medicines are covered, I was somewhat bemused that there was no mention of veterinary devices. Modern vets make much use of veterinary and medical devices. Many pet owners expect their pets to be treated as well as they are by the NHS, and they are ready to pay. Many large animals, particularly stud animals, are of considerable value to their owners, who also expect modern treatment.

With a growing market for veterinary devices there are areas in which the absence of these devices often involves medical devices, but the profession anticipates that the veterinary device market will only increase and specialise. The Committee will appreciate that size is an issue. At present, many vets manage by using human medical devices, but I am sure the Committee will understand that vets treat animals of all sizes, from a hamster to a chihuahua, to a prize bull. I tabled these amendments in anticipation of a vibrant veterinary device market. To use devices designed for a human body weight is not always appropriate.

My amendment calls for the Secretary of State to set up a working group to conduct a review into the regulation of veterinary devices, referencing animal welfare, human safety and the environment, and make appropriate consultations before laying a copy of the review before both Houses. Amendment 67B is also in my name and calls for a review of the impact of the Bill on veterinary medicines.

We are in a transition, and by the end of 2021 or thereabouts there will be a clearer picture about veterinary medicines, a year after leaving the EU. The Secretary of State should consult relevant bodies, such as the BVA, the NFU and animal welfare groups such as the PDSA and the RSPCA, but I think noble Lords should agree that there is a case for veterinary devices in the Bill.

[Lord Patel (CB) [V]]

My Lords, I am pleased to speak to government Amendment 131, merely to ask a question. The amendment will require reporting, which is positive and is to be welcomed. However, it leaves the matter of who is to be consulted to the discretion of the Secretary of State, because proposed new subsection (2) refers to

“such persons as the Secretary of State considers appropriate”,

while proposed new subsection (3)(a) requires the Secretary of State to take account of

“concerns raised, or proposals for change”,

but only those made by a person in accordance with subsection (2). Those persons are left to the discretion of the Secretary of State. It is not only the people who are consulted who are chosen; the list is produced by the Secretary of State.

To have any substance to it, the proposed new clause ought not to leave it to the whims of the individual Secretary of State to decide who ought to be consulted. There should be some minimal statutory list, or principles that can guide a list in practice, to give transparency and confidence. My question is quite simple: is it likely that the Government will produce a list of who they will consult?

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I put my name down to speak on this group primarily to speak to Amendment 106 in the name of the noble Baroness, Lady Thornton, but I will comment briefly on the excellent Amendment 67A from the noble Baroness, Lady Jolly. It seems to address an obvious lacuna in the Bill and I hope that the addition of veterinary devices would be a really simple procedure that the Government could take on board. I also commend Amendment 67B in the name of the noble Baroness, Lady Jolly, and associate myself with the remarks from the noble Lord, Lord Patel, on the concerns about the apparent weakness of government Amendment 131.

I wanted to speak to Amendment 106 because many of us who have been in different roles in politics over many years are used to receiving cries for help from people who feel as if medical systems have made them more ill, treated them badly and failed to live up to the oath of “first do no harm”. It is very hard for a person in your Lordships’ House or in politics to make a judgment call on what can be done and how people can be helped—on how systematic the issue really is and where this should be going. What we really need is a place where records are kept overall; it does not feel as if that is happening at the moment. The amendment lays down a way to address that. Of course, we have not heard yet from the noble Baroness, Lady Thornton, so I am interpreting what her amendment says.

There is also a broader point here, which we need to address throughout the Bill, and which I have been thinking about in the context of Covid-19. We really have a huge problem of trust, given the concern among significant parts of the public about how systems are working and whether decisions are being made in the right interests. One thing we need to do is to make sure that the whole system is transparent and open, and that records are there and accessible. We know of so many cases—the noble Baroness, Lady Cumberlege, set out some—where there tends to be a particular issue with the way that medicine has treated women.

There is also an issue in that the people who come to us and are able to make a fuss are often those who, in one way or another, have some form of social capital in their education, knowledge and ability to reach out and seek help. If we do not have regular systems of keeping records to see problems arising, it may be the most vulnerable who suffer without really knowing how to speak out and initiate action. I commend Amendment 106 to the Committee and look forward to hearing further discussion on it.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

I merely wish to ask the Minister about the consolidation legislation, to which he referred. Am I to understand that the Minister is saying that the Secretary of State will respond to Parliament, and that the matter will be available for debate?

[Lord Bethell (Con)]

I will get to back to the noble Lord with the specific answer to that question, if I may.

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[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I call the noble Lord, Lord Norton of Louth. Lord Norton? We will move to call the noble Lord, Lord Patel, and come back to the noble Lord, Lord Norton if we have time. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I will need to speak only very briefly because the noble Lord, Lord Field of Birkenhead, and the noble Baronesses, Lady Meacher and Lady Walmsley, have covered the ground extensively, fully and informatively. It is a privilege to be involved in an amendment moved by my noble friend Lord Field of Birkenhead. We have been friends, discussing such issues for very many years, although he was in a different House, so it is a pleasure to see him and support his amendment.

My noble friend Lord Field spoke from personal experience, and my noble friend Lady Meacher spoke extensively about the information available. In 1998, the Science and Technology Committee of the House of Lords recommended that there should be a programme to assess the medicinal use of cannabis and that ways should be found to use it. NICE has recommended one or two areas where it can be used, as has already been said. Very few NHS prescriptions have been given out, but more than 1 million people use cannabis preparations bought privately at huge cost. They use them because they find benefit from them. The report suggests that the people who benefit from it mostly suffer from chronic pain. Despite that, reports have been published where people with Alzheimer’s, cancer, chronic pain, Crohn’s disease and multiple sclerosis, to name but a few, found benefits from it. More than 20,000 publications on PubMed, not of clinical trials, but of people’s experience and data collected from patients, show that they have found it to be beneficial.

When recommending and assessing medicinal products using cannabis, NICE suggested that research should be carried out in six or seven areas. I do not know what research has been carried out. The problem with such a recommendation is that it does not recommend who should do the research. So I ask the question: who should be doing this research to explore the benefits that patients find in medicinal cannabis?

Private clinics prescribe more and more cannabis on a daily basis, and more and more clinics are opening in cities in England where cannabis is available. My noble friend Lady Meacher and the noble Baroness, Lady Walmsley, alluded to two important issues. One is that a way needs to be found to collect information on patients’ experiences and data to show why so many patients go to private clinics to get cannabis products and what benefits they derive from them.

I look forward to the Minister’s response, but I hope she may agree, as it would not require legislation or an amendment to the Bill, that the NIHR or the Department of Health and Social Care through the NIHR should establish a forum of specialists, including patients, to find a way forward to collect information on a more formal basis. I hope the Minister will respond positively to that. It has been a pleasure to take part in this debate.

[Baroness Jolly (LD) [V]]

My Lords, the amendment signed by my noble friend Lady Walmsley and others would require the Secretary of State to make regulations concerning medicinal cannabis and associated devices. The noble Lord, Lord Field of Birkenhead, made his case clearly and strongly. I have a family member who used cannabis as a painkiller towards the end of their life when pharmaceuticals failed. Given the huge relief it can bring to patients with conditions such as epilepsy, it is vital that barriers to access are removed. We have heard that since the law was changed in November 2018, only a very small number of prescriptions have been written for medical cannabis.

The noble Baroness, Lady Meacher, my noble friend Lady Walmsley and the noble Lord, Lord Patel, have for many years supported the use of medical cannabis for a small number of conditions. Very few patients have received their medicine on the NHS because NICE has yet to approve the use of cannabis in any context. Evidence is available, so why are the Government fighting shy of using cannabis or its derivatives, thus forcing individuals to become criminals by having to go abroad to countries where cannabis is legally available, but at a huge cost, and then smuggle it home? It does not make sense. We support the amendment.

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[Lord Patel (CB) [V]]

My Lords, I wish to concur with some of the points made; I do not speak against anything said by the noble Baroness, Lady Finlay. We are in complete agreement and I do not counteract anything that she says anyway. Having said that, most people look at medicines as things that cure disease. Most medicines do not cure disease. Symptoms are what patients experience, and we have to treat those symptoms. As an obstetrician, I have spent most of my life treating the symptoms of pain, prescribing morphine and heroin as painkillers to mothers who are suffering from labour pains. I could not measure their pain in any way except by what they told me about it.

The problem with database evaluation is that it looks for the size of the randomised trials. I suggest that observational studies that look at the experience of patients are a good enough database to evaluate whether the substance used is effective in alleviating their suffering. That is the sort of evidence that I hope NIHR will seek to establish a proper database. I am pleased to hear the Minister say that NIHR is looking at ways of dealing with this.

[Baroness Penn (Con)]

My Lords, the only thing that I will add is that the noble Lord, Lord Field of Birkenhead, said that this was about equality. My point is that MHRA’s approach to medicinal cannabis is the approach it takes to licensing all other medicines. So whatever approach we take to evidence, or how we look at the appropriate gathering of that evidence, will be based on the approach we take to all medicines. The way in which cannabis is treated is not as a different or exceptional case, and we will want to ensure that that is the case going forwards.

Covid-19: Vaccine

Lord Patel Excerpts

Wednesday 11th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, we are taking a four nations approach to the deployment of the vaccine. The Scottish NHS has been involved in all the arrangements we have been putting together and in both the Vaccine Taskforce, to procure the vaccines, and the Joint Committee on Vaccination and Immunisation, which has been discussing prioritisation. Furthermore, it has a voice at the DHSC, which is responsible for deployment.

[Lord Patel (CB) [V]]

My Lords, the announcement of the effectiveness of the Pfizer BioNTech vaccine being not only the first vaccine against Covid-19 but the world’s first vaccine against infection developed using messenger RNA is a huge scientific advance. There are challenges in delivering an effective national vaccination programme. As Professor Melinda Mills, in a report from the Royal Society and British Academy, pointed out, not the least is honest, transparent public communication free from hyperbole. Does the Minister agree? If so, who does he think would be best placed to lead the public communication of the programme?

[Lord Bethell (Con)]

The noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Penn (Con)]

To reassure the noble Baroness, I can tell her that the Opposition’s position on the government amendments is well noted. We will take away and reconsider the use of the term “person”, but there is a view that the safeguards that the noble Baroness is talking about are built in elsewhere, in how the clause would take effect. That does not mean, however, that we would not be happy to go away and look at those exact concerns, and see whether we can provide further reassurance. I am not a lawyer drafting the Bill, but that would be about looking at the terminology as well.

[Lord Patel (CB) [V]]

My Lords, I thank the Minister most sincerely for her full and comprehensive—I might even say persuasive—response. She is right to say that it has been a week since we debated this group, and even I had forgotten some things. Certainly, the venom certainly seems to have gone out of our debate.

The Minister reminded us what our anxieties were. She is right to point out that I referred to the word “person” in the government amendment, and also to the GDPR. I am pleased to hear that, on reflection, she, too, had realised why we were concerned about the use of data that might not be protected through the GDPR. Some questions remain.

The noble Baroness, Lady Thornton, has raised some important points, and I am glad that we may debate this subject again. It would be useful to have a discussion beforehand, if possible, because the word “person” is too amorphous—unless the definition could be confined as to what kind of person is meant. In her response, the Minister mostly covered organisations that might be involved in the regulation of medicines or in recommendations regarding medicines and devices, but the proposal as drafted goes much wider than that and would go beyond that. I will not say any more about that now.

The meeting that the noble Lord, Lord Bethell, arranged with the MHRA was useful, and it would have been better if we had had some of the information earlier. The information that I gave with regard to my Amendment 27 I had acquired from the industry. Of course, we got the same information from the chief executive of the MHRA. It would have been better if we had had that earlier—but that is water under the bridge. We know that there will be new ways of keeping us informed, and that will be good. At this point, I thank the Minister sincerely for her response, and I beg leave to withdraw the amendment.

Amendment 27 withdrawn.

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Moved by

[Lord Patel]

28: After Clause 2, insert the following new Clause—
“Innovative Medicines Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—“(9A) The Secretary of State must make a scheme to promote the availability of innovative medicines for human use within the National Health Service and must provide monies paid to him or her under subsection (9) for the benefit of that scheme to be known as the “Innovative Medicines Fund”.”Member’s explanatory statement
This amendment would require the Secretary of State to establish the Innovative Medicines Fund, as foreshadowed in the Conservative 2019 Manifesto; and provides that it is funded from rebates paid to the Government under the terms of the Pharmaceutical Price Regulation Scheme.

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[Lord Patel (CB) [V]]

My Lords, this amendment was tabled by the noble Lord, Lord Lansley, who unfortunately is not able to attend today. My name is on the amendment and I am very pleased to move it in his name.

This is an amendment that normally one would have thought the Government would have no difficulty in accepting, because it was in the Conservative manifesto at the time of the election. So if you are going to choose an amendment, choose the one that they cannot turn down. I am in the good position of making two speeches, one in the name of the noble Lord, Lord Lansley, and one in my own name. It will be interesting to see which one the Minister accepts, because I am not going to tell her which one is which—I may as well enjoy this while I can.

Patients in the UK often face delays in accessing breakthrough innovations due to the NICE technology appraisal process. This is particularly true of treatments for smaller patient populations, such as patients with rare diseases, where there is greater uncertainty around effectiveness due to the challenges of collecting sufficient data to satisfy NICE’s requirements. To overcome similar challenges and enable access to the latest cancer treatments, in 2016 changes were made to the Cancer Drugs Fund, to increase NICE’s flexibility in decision-making. Between July 2016 and November 2019, approximately 41,000 patients were registered to access 79 drugs, used to treat 160 different cancer conditions. Despite the clear benefits to patients, similar flexibilities have not been extended to other areas such as gene therapy and gene silencing—treatments for rare diseases where there is not much treatment available.

Amendment 28, in the name of the noble Lord, Lord Lansley, would add a clause to the Bill that would require the Secretary of State to establish the innovative medicines fund. This fund was promised in the 2019 Conservative manifesto. Like the Cancer Drugs Fund, its purpose would be to bring innovative medicines into use in the NHS. It would give NHS patients in England access to the latest new medicines, as advised by clinicians, and would give the NHS and NICE valuable data on their effectiveness, often adding information about drugs being used in clinical practice which is not normally available through clinical trials alone. There is an increasing need to extend these access schemes to disease groups beyond cancer, including neurodegenerative conditions such as motor neurone disease and Parkinson’s, as well as haemophilia, cystic fibrosis and sickle cell disease. These are diseases with a high unmet need for treatment, but also with real hopes for new treatment options, including gene therapy and gene silencing, as I have already mentioned.

This amendment would amend Section 261 of the NHS Act, which provides powers for the pharmaceutical voluntary price and access schemes, often known as VPAS, as amended by the Health Service Medical Supplies (Costs) Act 2017. An essential part of VPAS is to improve access to innovative medicines. The new fund would help to deliver this, alongside the MHRA Early Access to Medicines Scheme that we have already heard about. The predecessor to VPAS was the Pharmaceutical Pricing Regulation System. However, over the years, lack of access to innovative medicines has been a source of angst in the industry about the scheme and, for many of us, is part of a system that fails patients. It was not only industry that did not like the scheme; it was denying treatments to patients. We should not have a stand-off between the NHS and drugs companies, with patients losing out in the process. We should have a scheme that adequately rewards the value that is inherent in medicines and also ensures that the NHS is able to provide the treatments that patients need.

The current VPAS sets a budget limit on the NHS drugs bill. If it is exceeded, the industry will provide a rebate. In the past, the NHS has seen rising drug costs but has not seen the rebate—so the NHS took the rebate but did not reinvest it in other innovative medicines. By way of the Innovative Medicines Fund, the NHS, the life sciences sector and patients would all see the benefit of the rebate. The proposed new clause would require the rebate to be made available to the fund, and it is that rebate which will provide the money for the fund. I hope—and I hope that the noble Lord, Lord Lansley, will agree—that it will be open to Ministers to take advantage of these powers to provide additional resources to the fund, according to its needs. The clause will provide the means by which the Government can deliver on their manifesto pledge and, in doing so, deliver to patients, some of whom are in great need.

I do not see how the Government can resist Amendment 28; they can only improve on it. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am glad to support the noble Lord, Lord Patel, and I have a great deal of sympathy with this amendment. Of course, I speak as one of a long line of former Ministers who have wrestled with the tension between a cash-restrained NHS and the imperative to invest in new medicines and devices. I have come to the conclusion that we are not going to see the investment we want to see in these new medicines without a radical change of approach.

When we debated access in Grand Committee a couple of meetings ago, the Minister used words to the effect that he would not go anywhere near reimbursement. That is at one with the way the NHS regards drug costs: as a price and a cost to be pared down rather than as an investment in patient care. The unwillingness of Ministers to tackle the issue of reimbursement to the industry in a way that incentivises the use of new medicines is, I think, very disappointing. I do not think that there is any way around this, unless we top-slice some of the resource for the NHS and distribute it separately for investment in new medicines.

The noble Lord, Lord Patel, referred to current and previous agreements with the industry. I want to go back to the 2014 PPRS agreement, which does I think provide a model for us. It provided assurance on almost all of the branded medicines bill for the NHS, so the bill stayed flat for the first two years of the scheme and grew slowly after that. The industry made quarterly payments to the Department of Health when NHS spending on branded medicines exceeded the allowed growth rate. The quarterly payments that the industry made could have been used to fund new medicines—but, as the noble Lord, Lord O’Shaughnessy, mentioned last week, it is very hard to explain what exactly happened. With a cap in place and with reimbursements being made by the industry, the NHS proceeded to try to ration drug costs at local level. So, instead of having a virtuous circle where essentially the industry guaranteed the cap on drug costs in order to allow for investment in new medicines, we had a double whammy. The industry price was pared down and the NHS continued in its bad old ways of trying to prevent new medicines being accessed by patients.

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[Baroness Penn (Con)]

I am reminded that my noble friend Lord Lansley referred to the collective noun for former Health Ministers as a “frustration” of former Health Ministers. I can tell my noble friend that the engagement exercise will involve the pharmaceutical industry, the NHS and associated bodies and patient groups. That is the level of detail that I can give to him today. I was very pleased with being able to say “quarter 1” next year; it felt to me like a very specific timeframe for when that engagement exercise would be undertaken.

[Lord Patel (CB) [V]]

Thank you, my Lords. I apologise to the Chair for jumping in. I forget that, in the new world, I do not speak unless instructed to do so.

I thank the Minister enormously for her response. She mentioned the frustrations of the former Ministers. If she thinks that former Ministers get frustrated, think about us lesser mortals who have suffered the former Ministers when they have not listened to our arguments. Maybe that should be taken into account, too.

I thank all noble Lords who have taken part. They have spoken with passion and commitment. This has been referred to by several people, but I do so again. The noble Lord, Lord Hunt of Kings Heath, has been pursuing this passionately and eloquently for a very long time. He has made an important point: if the medicines are available and people are suffering, why do we keep arguing about health and drug budgets and how to deliver it? The principle should be how we can get those drugs to the patients who might be suffering. He is right. If a rebate is available, where did the money go? The rebate was a drug fund rebate to be reinvested, you would have thought, in people getting the medicines.

No doubt the Minister is aware that there seems to be complete consensus around this amendment. I hope that it does not need to go to Report but, if it does, Ministers will be aware that there will be complete consensus. I hope that the Minister makes rapid progress with sorting this out. In the meantime, I thank all noble Lords and the Minister most sincerely for taking part. In begging leave to withdraw the amendment, I hope that the noble Lord, Lord Lansley, will feel that we gave it enough airtime and passion.

Amendment 28 withdrawn.

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Moved by

[Lord Patel]

40: Clause 4, page 3, line 25, at end insert—
“(f) about requirements to consider babies, children and young people in research about new medicines, in a manner similar to the EU Paediatric Regulation.”Member’s explanatory statement
This amendment is to ensure that in the development of new medicines and clinical trials, data related to children is taken into consideration.

[Lord Patel (CB) [V]]

My Lords, I shall curtail my remarks, as time is limited and this is very much a probing amendment. It draws attention to the need to ensure that paediatric regulation-specific measures that preside over the licensing of medicines to better protect the health of children, are reflected in future legislation regarding clinical trials in the United Kingdom.

New medicines licensed in the EU are currently subject to an EU Parliament directive that requires research about new medicines to consider babies, children and young people. The directive means that standardised procedures are in place for sponsors to plan and conduct studies. To get new medicines intended for use by children licensed for marketing in the EU, sponsors must have in place a paediatric investigation plan that aims to ensure that the necessary data are obtained through studies in children. In short, new medicines applying to be licensed for use by children must be trialled by them. It is often the case that medicines trialled in adults are then given in lower doses to children.

New medicines trialled in the United Kingdom are currently subject to this regulation. Moving on, there are clear clinical reasons why it is important for babies, children and young people, as they may show differences from adults in their response to and tolerance of medicines. To ensure that new medicines are safe for their use, they must be involved in clinical trials. That is the important point of my modest amendment.

Furthermore, there is a commitment and a key pledge in the NHS long-term plan to raise to 50% by 2025 the involvement of children and young adults in clinical trials. If there is no regulation requiring that data be collected in clinical trials with children, we will not achieve this. So all I seek is an assurance from the Minister that the Government and the MHRA are well aware of this and that the paediatric regulation will be considered whenever the clinical trials regulations are drawn up by the MHRA. I beg to move.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

My understanding is that the noble Lord, Lord Lansley, has withdrawn, so I call the noble Baroness, Lady Jolly.

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[Lord Bethell (Con)]

My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.

I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.

I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.

It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.

The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.

I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.

[Lord Patel (CB) [V]]

I thank the Minister for his response, as I thank all other noble Lords who have spoken. A small point was raised, with a good, short debate and the right response. I beg leave to withdraw my amendment.

Amendment 40 withdrawn.

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When you take that assurance given by the Leader of the House, and the concurrence of the Constitution Committee with the Delegated Powers Committee, the Minister at least has some questions to answer. For me, it takes us right back to our first debate on the proposal for a sunset clause. The Bill is riddled with executive powers under the guise that they need to have flexibility. Even if it is accepted that flexibility is needed in the short term, I do not believe that that justifies permanent legislation. I look forward to the Minister responding here, and no doubt on Report when we come back to the sunset clause.

[Lord Patel (CB) [V]]

My Lords, I support these amendments. They touch on the issues and arguments returned to in respect of amendments to Clauses 15 and 42, which set out the procedures to be followed in exercising these powers, as was mentioned by the noble Lord, Lord Hunt of Kings Heath, its unjustified use of negative procedure and this case of protocols. Clauses 6 and 15 provide that the Secretary of State can disapply certain provisions of the medicines and medical devices regulations

“in circumstances which give rise to a need to protect the public from a risk of serious harm to health.”

Such provisions may be within the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Medical Devices Regulations 2002. However, they also may refer to those provisions that are still to be drafted at the current time and are thus unknown and not yet subject to scrutiny.

I recognise that it is necessary to be flexible in the face of an emergency situation as in the current pandemic. However, in its present form this is another example of broad-reaching powers falling outside of that which is reasonable and proportionate. While the disapplication of certain provisions using this power can be exercised to regulations under the affirmative procedure, they may also be passed in certain circumstances by the negative procedure, and, as in these amendments, by protocol. The use of a protocol, in particular, bypasses Parliament, and therefore is unnecessary. I support these amendments.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

The noble Lord, Lord Blunkett, has withdrawn, so I call the noble Baroness, Lady Jolly.

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[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.

[Lord Bethell (Con)]

I welcome the challenge from the noble Lord, but the examples we have given are also more recent, from the 2009 swine flu attack. The protocols were also used in the Salisbury Novichok attack. I know from my own experience that public health disasters can throw up extremely unexpected hurdles and barriers to action, in the form of legislative surprises. Therefore, these powers are not considered to be frequently used. In fact, they are never used—noble Lords will all breathe a sigh of relief—but public health challenges are likely to be a feature of the future, and it is prudent to put in place the protections we need in order to provide for them.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

Debate on Amendment 19 resumed.

[Lord Patel (CB) [V]]

Thank you, Chairman. It is a pleasure to resume where the Committee left off last Monday. I will speak to Amendment 19, in the name of the noble Baroness, Lady Sheehan. I congratulate the noble Baroness, who spoke with eloquence and passion. On Zoom, you can see faces more clearly and you could tell by looking at her while she was giving her speech that she really feels for the cause. I will speak briefly to support the noble Baroness in her efforts to use human rights legislation to get medical therapies available to patients, particularly in developing countries.

I am no expert in human rights law, but I have seen at first hand what lack of everyday medicines, which we in developed countries have easy access to, does to patients in need in developing countries. In my own medical speciality of obstetrics, I have come across situations where mothers die, or end up with lifelong disability, for lack of availability of cheap medications that would have saved them from dying of childbirth-related haemorrhage. Medicine that costs less than £2 would have saved those mothers’ lives in a very short time.

Despite progress, over 2 billion people worldwide face obstacles in getting the medicines that they need. The current research and development model is mostly market driven and is ill equipped to deliver medicines for neglected tropical diseases and emerging infectious diseases that only affect those in developing countries. Only 1% of the total number of new medicines coming to market are licensed for treating tropical and rare diseases in poorer countries. Another big barrier is the pricing mechanism that makes what we may regard as cheap medicines unavailable in poorer countries because of cost. A human rights model, proposed by the WHO and the United Nations, for making more treatments available in poorer countries, faces serious obstacles because of world trade and patent regulations. The monopoly market power of patent rights plays against the availability of medicines for poorer countries.

All that being said, a soft-power model can sometimes be effective. The Bill & Melinda Gates Foundation has had considerable success in its efforts to create an access-to-medicine index for pharma to demonstrate its commitment to getting medicines to the developing world. One example is the generic medicine for treatment of hepatitis C, but some pharma companies prevent early recourse to generic versions of medicines through extending patent laws by using tactics such as data exclusivity. I heard an announcement today that, if the Sanofi and GSK vaccine works, they will provide 200 million doses of it free to the developing world. That is good news, but it is far away from the billions of doses that we will require.

If there is a serious desire for the world to make treatments available to patients in poorer countries, at a price that they can afford, laws will be needed to change the market-driven model to a more rigidly applied human-rights-driven one. The noble Baroness is right to highlight the problem. The Government can help by working with other Governments to create opportunities for easier access to medicines for developing countries. There has to be a way to get around the model of profit versus patients.

[Lord Stunell (LD) [V]]

My Lords, I endorse what the noble Lord, Lord Patel, has said about the excellent speech of my noble friend Lady Sheehan. I support her arguments and those of all the previous speakers. I could never hope to bring the level of expertise that the noble Lord, Lord Patel, does to this subject.

I want to focus, very simply, on what happens next—and what happens next is based on what has happened so far. Proposed new subsection (2)(d) in Amendment 19 is an affirmation of the International Covenant on Economic, Social and Cultural Rights, which was first passed in 1966 and the United Kingdom Government ratified 10 years later in 1976. My first question, therefore, is to ask the Minister: do the UK Government still stand by that covenant, or is it another piece of international legislation that can be broken in certain limited and specific circumstances? I think that noble Lords will want to hear the Minister say very clearly that the Government are still committed to the full meaning of that covenant. If he does, I hope he will also acknowledge that the key feature of that covenant is that it requires access to medical care and treatment to be affordable and available to all. That is exactly what the second part of Amendment 19 is talking about. It aims to give teeth and real substance to that covenant and to make sure that medicines and treatment are indeed affordable and available to all.

What is the risk that we are guarding against? Why do we need to do this? The noble Lord, Lord Patel, also focused on those questions. Although there are many risks, the leading risk which this amendment deals with is greedy pharmaceutical companies. The story of Gilead selling its drug in the United States for £2,300, when it can be manufactured with a profit for £9, was drawn to our attention by the noble Lord, Lord Alton, on Monday. That is just one of many examples of companies unscrupulously using their monopoly to reap profits at the expense of those who need the treatment. Sadly, there have been many other examples of it. In the current worldwide search for a vaccine, the pressure on companies to deliver a treatment, and the pressure from communities throughout the world to receive it, means that the risk of profiteering and gouging are very much higher.

Of course pharmaceutical companies are fully entitled to recover their costs, and that should include the costs of their research, including for the research on products which they cannot bring to market for one reason or another; and of course they should be entitled to make a profit as well. But in the case of Covid-19 vaccines, nearly all the money has been pumped into the research from the public via Governments around the world. Hundreds of millions of pounds from the United Kingdom Government have gone to these firms. The Government therefore have some really powerful levers to pull to make sure that there is fair and equitable pricing by those companies and fair and equitable sales around the world.

Of course, the truth of the matter is that we have a WTO TRIPS agreement that protects pharmaceutical companies’ monopoly purchasing. But attached to that is the Doha declaration of 2001, which gives Governments the right to step in to prevent that profiteering and price gouging. Under the declaration, the United Kingdom has in principle the right to grant compulsory licences so that other manufacturers can make the product in an alternative way at an alternative price. We need to hear from the Minister today that the UK Government will use the powers available to them in the Doha declaration to prioritise the safeguarding of access to medicines for all right round the world. “All” has to mean all, not just within the United Kingdom but worldwide, as my noble friend Lady Sheehan made so clear, especially in low and middle-income countries.

The role of the United Kingdom in ensuring that an effective worldwide response to Covid actually happens may well require compulsory licensing using the basis provided by the Doha declaration. Certainly, having that basis, and having this amendment passed, gives the Government a credible threat that they will indeed make sure that medicines are available for all. I look forward to hearing the Minister agree that, if not Amendment 19 itself, at least a loud and clear commitment from the Government to implement their powers under the Doha declaration is very much a part of their armoury in tackling the current situation.

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[Lord Patel (CB) [V]]

My Lords, it is always very difficult to follow the noble Lord, Lord Alton of Liverpool, because his speeches are always so powerful, convincing and well researched, so I do so with some hesitation. I absolutely agree with him that it is abhorrent that the plastinated bodies of human beings are used for commercial purposes in exhibitions. It is certainly not science, and I do not think it is art either. It should be banned, and I was surprised that the exhibition took place.

Tissue and organs were taken from children at the Alder Hey Hospital. I was involved in the subsequent inquiry and heard the harrowing stories of parents whose children’s organs—there were thousands of them—were taken and stored without their consent.

I was touched by and support the powerful speeches of all the preceding speakers. The noble Lord, Lord Hunt, raised an important issue and I agree that his amendment is a modest provision asking the Government to look at the issue and to amend the Human Tissue Act if necessary. In the past, I chaired for four years the Medical Research Council’s ethics committee, and for more than four years I have chaired the UK Stem Cell Bank. I am also familiar with the research ethics committee—at one time I was its chairman—of the National Patient Safety Agency, which the noble Lord, Lord Hunt of Kings Heath, chaired before me, when it introduced a nationwide regime for examining consent through that ethics committee, which is now a statutory committee. Noble Lords have rightly said that the regulation of consent in the use of tissue and organs is strict in the United Kingdom. There is strict monitoring in the use of tissues for any purpose. The noble Lord, Lord Hunt, alluded to the fact that the law on the importation of tissues is lax. If that is true, it needs to be examined. I have looked into the current law and at various websites covering human tissue importation and, in particular, the issue of consent. The noble Lord, Lord Alton of Liverpool, asked how we can be certain of the validity of the consent that was given. I agree it is an important point, and the Government should seriously consider Amendment 24.

On the issue of research, I will tell a story about HeLa cells. I do so not to immortalise HeLa cells, although they are immortal, but to immortalise the person from whom the tissue sample was taken on 8 February 1951: Henrietta Lacks—which is why they are called HeLa cells. She was a black American mother of five who developed extremely aggressive cervical cancer. She attended Johns Hopkins Hospital, in Baltimore, and a tissue for diagnostic purposes was taken from her cancer. The tissue was then passed on to a laboratory that was trying to culture cell lines. Ever since then, HeLa cells have been used all over the world to develop treatments in all kinds of therapies. For instance, Salk used them to develop the Salk polio vaccine. They were used to develop treatments for cancers, such as breast cancers. They were used for xenografts, again to develop cancer treatments. They are also being used to study aging processes. As our cells age they eventually become senescent and inflamed, which produces some of the chronic diseases that humans suffer from. That does not seem to happen with HeLa cells as regards telomerase, which controls the size of telomeres, which is part of the aging process. HeLa cells have been used for all kinds of purposes.

I have another concern about the commercialisation of tissue use. In advertisements on the internet—noble Lords can see them there if they wish—many commercial companies say: “We will supply tissues to industry for the testing of drugs”. What consent was given for the use of that tissue? Does the HTA have to give permission to import this tissue or ask where it came from? When the Government examine this issue I would only ask them to distinguish between tissues, organs and cell lines and ask why they should be treated differently. I do not say that regulation is not required; I am simply saying that, when it comes to importation, we need to have a clear understanding of why cell lines should be treated differently from tissues and organs. I support the amendment.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The noble Baroness, Lady Stroud, who is next on the list, has withdrawn so I call the noble Lord, Lord Sheikh.

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[Lord Patel (CB) [V]]

My Lords, I will speak to Amendment 97 in the name of my noble friend Lord Kakkar, to which I have added my name. Before I do so, I have a comment in response to an important question asked by the noble Baroness, Lady Cumberlege, which my noble friend Lord Kakkar answered. How do you test the effectiveness of a device which is an implant, and is likely to remain in the body permanently? This is opposed to implants such as pacemakers—as I alluded to on Monday—where, in one example, a device was unsatisfactory after having gone through testing, but was then implanted in 1,400 patients before its faults were clearly recognised. In that case, it was possible to remove the device, and put in one which functioned better. The testing of an implant which is likely to be permanent must be more rigorous, in terms of its tissue reactivity, in the training it will require, and in the possible harm it can do. This is particularly true for things like mesh that are likely to be embedded into the tissue. People claimed that that mesh was safe because it had been used by surgeons for years for hernia repairs. As I said on Monday, I have never used mesh for any of the surgery I did, so I do not know its performance. The question of the noble Baroness is quite right: it does not mean that we do not have to progress with finding new medical devices which would be effective; it means that we need to ask significant questions, depending on the device we are talking about. I may not have answered her question, but I have tried to identify ways we might do that.

My noble friend Lord Kakkar has made a very important point about the need for medical devices to be tested for their effectiveness in the functions they are supposed to provide prior to their being granted full market approval. Generally, the design of a medical device is regulated by its essential principles of safety and performance with respect to its design and construction. Less attention is paid to its clinical effectiveness throughout its expected life, whatever that might be. Medical devices play an important role in enhancing patient quality of life, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy. The UK, with its strong research base, and with the NHS at its core, is well placed to generate the high-quality evidence needed. Guidance is needed to generate, implement and produce the evidence required to foster innovation. Adopting engineering principles of continuous monitoring, reporting of accidents or near misses—similar to post-market surveillance of medical devices—is important. In developing medical devices, dialogue between clinicians, manufacturers, and end users—the patients—to identify which devices need to be developed is valuable, but not often followed.

While not as robust as a randomised control trial, observational studies are important in identifying rare, catastrophic and delayed harm. Furthermore, medical devices are less amenable to controlled trials, being part of a complex system of care, involving people in other systems. The UK has an opportunity to develop specialised medical device trial centres and clinical networks to oversee early to late-phase trials. That initiative would benefit patients and put the UK in a lead position to develop safe and effective medical devices.

The Royal Academy of Engineering and the Academy of Medical Sciences, of which I am a fellow, have much to offer in such an initiative. With his amendment, which rightly promotes the requirement that medical devices should demonstrate their clinical effectiveness prior to a full market authorisation licence, my noble friend Lord Kakkar has also provided an opportunity for the UK to develop leading-edge medical device regulation, and be a place for developing safe and effective medical devices.

[Baroness Jolly (LD) [V]]

My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.

Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.

Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.

The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.

Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.

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Moved by

[Lord Patel]

27: Clause 2, page 2, line 35, at end insert—
“( ) Regulations under section 1(1) must make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay for the United Kingdom to get early access to new medicines.”

[Lord Patel (CB) [V]]

My Lords, I speak to Amendment 27, and I am immensely grateful to the noble Lord, Lord Hunt of Kings Heath, for adding his name to it. He adds not only his name, but his weight and expertise, which I look forward to hearing.

I beg the indulgence of the Committee, as I may be long, as I will also speak to the government amendments with my own, as I am allowed to speak only once. My amendment is a short and simple probing one to explore how the Government will mitigate against delays for UK patients getting early access to medicines, particularly innovative treatments such as gene therapy, gene silencing, other treatments for rare diseases, and cancer drugs. Part of the problem, as mentioned on our previous day in Committee, is that we are not able to speak to the MHRA and other regulators to know what their plans are. Yet, to my surprise, I was sent something yesterday evening, which I will refer to in a minute.

I understand that the MHRA are developing plans, but it is not clear whether that includes working with other regulators, NICE and NHS England for patient access to treatment. I understand that a new medicines designation will be created, alongside an integrated framework across healthcare agencies to enable innovative treatments to be approved more quickly. As gene therapy and other gene-based treatments, such as gene silencing, are one-time treatments, they require a different approach to the evaluation of efficacy. While the UK has a rigorous process of regulating and reimbursement, it is known to be lengthy, delaying access to treatments. When it comes to getting cancer treatments to patients quicker, clinicians are asking for complex innovative design trials to be implemented instead of the usual clinical trials. As mentioned previously, patients with rare diseases are concerned that if a UK regulator does not work with the EMA or the FDA, a lack of access to patient numbers and data will mean that UK patients miss out on treatments.

I turn now to the information that I have received. During Covid, the MHRA have been exemplary in rapidly allowing clinical trials to be conducted and therapies to be brought to patients very quickly. A process that would normally take two years was completed in six months for some medicines. Looking to the past, as was mentioned on Monday by the noble Lords, Lord Blunkett and Lord O’Shaughnessy, NHS England was very committed to ensuring that the UK was the first country in Europe to provide access to the two latest chimeric antigen receptor T-cell drugs, commonly known as CAR-T therapies, an immunotherapy for cancer. It was a very positive case study of what could be done, but this has not been the experience for all treatments. We need to ensure that the new NICE framework is fit for the future for the high number of innovative treatments coming through. There are potentially 27 cell and gene therapies that will need to be appraised by NICE within the next three years.

I understand that the MHRA has published a guidance note on new assessment routes from the end of the Brexit transition period, to which NICE needs to be more aligned. In addition to continuing to accept EMA decisions for two years, the MHRA has also announced its intention to design new approaches to market: from 1 January 2021, it will introduce an accelerated assessment procedure and then reach its opinion on approvals within 150 days of submission of a valid application. Applicants interested in seeking accelerated assessment are told to contact the MHRA in advance of the intended date of submission.

Rolling review is a new route for marketing authorisation applications which offers ongoing regulatory input and feedback. It is a good idea if the regulator wants to get involved at a very early stage in the development of clinical trials and hence get treatments to patients early. As to overlapping an integrated pathway for new medicine, the MHRA is, I gather, working with partners across the system, including NICE, to develop a streamlined route to market for new medicines. This will include a new medicines designation and an integrated pathway with multiple entry points. That is all good news, and I hope it will all come to fruition very quickly so that patients can get the medicines they need, particularly for rare diseases.

I turn to the government amendments in this group. As I said earlier, I seek the Committee’s indulgence as I will need to deal with these amendments at some length, particularly their amendment on information sharing. The Minister said in a letter that the provision was to protect public health. He said that information is currently shared between the MHRA and the Veterinary Medicines Directorate and international partners to support their work in ensuring that medicines and medical devices are safe. Information sharing currently falls within the purview of the EU, and the Minister implied that this government amendment is intended to ensure the capacity of the MHRA and the VMD to continue to collaborate internationally to ensure public safety. In principle, this amendment appeals to common sense. The MHRA and the VMD need to share information with international partners to ensure the safety of devices and medical products. However, the issue is the breadth of the amendment’s wording and the vague terms used in drafting the power.

The amendment inserts new clauses after the current Clauses 6, 10 and 35, which set out that the relevant authority may disclose information it holds in connection with human medicines, veterinary medicines and medical devices

“to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation”,

of human medicines, veterinary medicines and medical devices. That immediately raises several points. First, the provision refers to

“information which a relevant authority holds”.

That is a broad construction and could potentially cover all information in patient records relating to medicines and medical devices. The term “in connection with” is broad and vague. Does it mean any information tangentially related to medicines, veterinary medicines and medical devices? Could it include any information in medical records relating to the use of medicines for patients? No definition of

“person outside the United Kingdom”

is given, which leaves it open to broad interpretation and places no limits on the category of persons to whom information may be disclosed.

The purposes of information disclosure are also broad and could relate to the fulfilment of requirements of potentially any international agreement. That is particularly highlighted by the use of “or” in reference to arrangements “relating to the regulation” of medicines and medical devices. It means that international agreements that require disclosure of information do not need to relate strictly to the regulation. In fact, despite the arguments detailed in the letter of the noble Lord, Lord Bethell, relating to information disclosure for purposes of promoting public safety, there is no mention of public safety in the purposes of information disclosure in the amendment. The purposes are left to be determined by any international agreement, and this power is exceptionally broad.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Baroness Burt of Solihull (LD) [V]]

My Lords, I speak to Amendments 10, 12 and 74, to which I have added my name. Although I support all the amendments in this group, they pretty much do the same or a similar kind of job, but I added my name to those amendments specifically because they speak to safety being paramount for new drugs and devices. I say that because the excellent Cumberlege report tells the graphic and heart-rending story of what happens when it is not.

We have heard about the effects of the drugs Primodos and sodium valproate from the noble Baroness, and other noble Lords will cover those areas. My interest relates to mesh and what happens when insufficient care is taken in the implementation and tracking of the well-being of women who have had it inserted. When it goes wrong, it really can ruin the life of the woman affected. Noble Lords may recall the case that I mentioned on Second Reading of how Jane’s life has been ruined by mesh—not just physically but emotionally and economically. The noble Baroness described such things as well. Yet the surgeons who did this to her seem to exhibit no remorse and have closed ranks, denying the very existence of some of the pieces of mesh inside her.

It makes my blood boil to hear those harrowing stories, and the noble Baroness had to listen to such testimony from victims for two years. As she says in her report, this took its toll on her and the other members of the panel, but how much worse must it have been for the victims themselves? Yet we see phrases in the Bill such as,

“the appropriate authority must have due regard to ... the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.

Attractiveness? What does that even mean? My noble friend Lady Jolly spoke on the third group of amendments about the multiple interpretations that the term could have. Are we trialling drugs and devices on human beings so that we can subsequently flog them abroad? I am sure that the Minister will deny that and give us a proper definition of the word.

Attractiveness and availability must be a low priority compared with safety and that is why I strongly commend the amendments. If the Minister believes that safety must be the overriding consideration, I trust that he will have no difficulty in accepting them.

[Lord Patel (CB) [V]]

My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.

I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.

The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.

The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.

There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.

A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.

Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.

I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.

[Baroness Hollins (CB) [V]]

My Lords, it is a pleasure to follow my noble friend Lord Patel. I commend his work on patient safety over many years. I strongly support the amendments in this group, which are intended to improve patient safety—in particular, Amendments 10 and 12 tabled by the noble Baroness, Lady Cumberlege. I withdrew my own, very similar amendment and added my name to that of the noble Baroness.

In the present drafting, as the noble Baroness has explained, there is no explicit hierarchy of the three stated principles: safety, availability and attractiveness of parts of the UK as a place to conduct clinical trials or supply medicines, yet this Bill could be so much more effective if it was more explicitly about patient safety. These amendments put patient safety first, as so clearly called for in the noble Baroness’s shocking recent report First Do No Harm. I quote from that report’s foreword:

“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.”


I simply stress that safety must apply across all aspects of the development and provision of human medicines with respect to both mental and physical illness. Noble Lords may be unfamiliar with the national STOMP programme, launched in 2016—STOMP stands for stopping over-medication of people with a learning disability, autism or both. Public Health England says that, every day, between 30,000 and 35,000 adults with a learning disability take psychotropic medications when they do not have the health conditions the medicines are for—they are also prescribed to children and young people—yet such medicines may have serious side effects, including adverse effects on their mental and physical health.

I do not wish to speak at length about this or other aspects of these amendments other than to stress that patient safety must be the foremost consideration in this Bill.

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[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?

[Lord Patel (CB) [V]]

Yes, I am.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

I am sorry. We could not hear you and we still cannot see you.

[Lord Patel (CB) [V]]

Can you see me now?

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

Ah! You are with us in all your glory. Please continue.

[Lord Patel (CB) [V]]

Not much glory, but thank you very much.

Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.

The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.

However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.

I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.

With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—indeed, it would appear to prevent—the argument being made that attractiveness and the safety of medicines and medical devices can sometimes be in conflict. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.

--- Later in debate ---

[Lord Blunkett (Lab)]

My Lords, although I was the shadow Health Secretary for two years in the 1990s, I speak with some temerity because the three contributors that we have just heard have expertise on this issue that I do not. I rarely say that when I decide to speak in Committee or on the Floor of the House.

I want to make three points. One was made by my noble friend Lord Hunt but reinforces the points made by the noble Lords, Lord Lansley and Lord O’Shaughnessy. It is about innovation and the way in which the acceleration of known therapies—in this case, gene therapy—can make such a difference. My much-missed and much-loved friend, the late Baroness Jowell, pioneered the idea of rapid, speedy throughput of potential new therapies, including gene therapy, and ideas to fruition. As a Minister at the time, the noble Lord, Lord O’Shaughnessy, was extremely helpful and supportive. I will always be grateful to him for attending Tessa’s funeral and being really committed to seeing her ideas go forward. I am glad that he was able to contribute this afternoon. I hope that the Minister will bear in mind the reality of what happens to individuals in practice and not forget the continuing campaign and support of Tessa’s family, particularly her daughter and her son.

I want to touch on two tangential issues. One is the real problem we have with substituting for procedures that are withdrawn because overseas manufacturers decide that they will not sell to us, including how we can initiate alternatives within the research available to us. Eighteen months ago, I had a procedure on my hand. I was told by the consultant that this procedure avoided having to have surgery; your Lordships and those who are taking any notice of this debate will be aware that hands are rather critical to me in a whole range of ways, so it was a very attractive alternative. However, she told me that I was one of the last patients to benefit from it because it had been withdrawn by an American supplier.

The very opposite happened in my old constituency, where Swann-Morton, a mutual that has existed for more than 80 years, produces a large number of cutting-edge facilities, from old-fashioned scalpels to the most modern and up-to-date tools for doing the job. I want to know what we will be able to do post Brexit to protect the likes of Swann-Morton, which is a big employer in the locality—it is a mutual in every sense, including the decisions taken by the employees themselves —from being excluded from markets that they previously had obvious access to, which reduces their competitiveness and ability to proceed. They have also been hit by Covid, of course; the fewer the procedures undertaken through the NHS, the more this hits the budgets of those who rely on a continuing flow of orders.

I could not find another niche in this particular group of amendments to make my point, so I have used my ingenuity. I am grateful for not having been heckled.

[Lord Patel (CB) [V]]

My Lords, there is no need for me to speak at length because I agree with much of what has been said. It has been fascinating to listen to how people who were Secretary of State and Minister of Health change, once they are not in that position, in fighting for resources and more innovation to be brought into the NHS quicker. I commend that, but I wish it had happened when they were in charge. I say this tongue in cheek to tease them, of course.

I support the amendments in the names of the noble Lord, Lord Lansley, and Amendment 124 in the name of the noble Lord, Lord Hunt of Kings Heath. What they both said is correct: the NHS is very slow to bring in innovation. Also, when innovations are available that will benefit patients, trying to use them is very difficult as a clinician because they are sometimes quite unique and not routinely used.

I will give noble Lords an example. Standard radiotherapy is used for cancer treatment, but occasionally the cancer does not respond, so the radiotherapist and medical oncologist would on very rare occasions want to use what is known as CyberKnife—focused radiotherapy that deals with the tumour but does not damage the surrounding tissue. I am told that to do this would require a request to be sent through the NHS trust system to the CCGs to get their approval, but this treatment is usually required now—today—not in about three weeks’ time, because the patient is in the advanced stages of cancer.

This is just one example; there are lots of others. What the noble Lord, Lord Hunt, said at the end of his speech was right: while this debate is maybe not directly linked to regulatory issues in medicines and devices, a much wider debate needs to be had on whether we have evolved processes that are counterproductive to bringing in or even developing innovations, as the noble Lord, Lord Lansley, referred to on a previous group of amendments. I am slightly hesitant to say that.

The original concept of NICE was to have an opportunity to bring modern innovations rapidly into the NHS. Yes, there was another side to it: that it should be effective and not increase costs unnecessarily. I know this because I was associated with it at the time of its formulation. I took a different route; I did not continue to be involved with NICE, but I became chairman of a similar organisation that the Scots established, at the time called the Clinical Standards Board for Scotland. I deliberately separated bringing innovations into the clinical area from the area of medicines by having the Scottish Medicines Consortium be quite different. However, the concept was the same in England and Scotland. Unfortunately, we need to get back to finding how we can bring in modern innovations more quickly and how we can use our science and the NHS as the core to make more innovation. However, I commend what the noble Lords, Lord Lansley and Lord Hunt, had to say.

[Baroness Barker (LD)]

My Lords, I thank your Lordships for allowing me to come off the substitutes’ bench to take part in place of my noble friend Lady Jolly. I did not have the opportunity to speak on the last group, but if I had I would have strongly echoed the words of the noble Baroness, Lady Thornton. I do not believe that the Government’s amendments go anywhere near strengthening, clarifying or taking away the reservations that many of us have that the definition of “attractiveness” is one that largely depends on the watering down of regulation and standards and the increasing of commercial competitiveness. That is very much germane to this set of amendments, because it is against this backdrop that the amendments from the noble Lord, Lord Lansley, sit.